Postoperative Acute Kidney InjuryNCT04922866
Predictive Nomogram for Postoperative Acute Kidney Injury (AKI) in Elderly Patients Following Liver Resection
An observational study of Postoperative Acute Kidney Injury, run by Chinese PLA General Hospital at 2 sites in China.
Trial summary
Acute kidney injury (AKI) is a severe complication after liver resection and is associated with morbidity and mortality. The incidence of postoperative AKI is significantly higher in elderly patients, especially in those with comorbidities. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Postoperative Acute Kidney Injury
- How many people
- 843 participants
- Where
- 2 sitesChina
- Study dates
- 1 Sep 2020to 30 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients (aged ≥ 65 years) with benign and malignant liver diseases of the Chinese PLA General Hospital HPB (Hepato-Pancreato-Biliary) Center undergoing liver resection from 2012-2019
Who may be able to join
- Elderly patients aged ≥65 years
- Benign and malignant liver diseases
Who cannot join
- Emergency operation
- Liver transplantation
Trial locations and contacts
2 sites in 1 country.
China2 sites
Chinese PLA General Hospital
Beijing, Beijing Municipality
Chinese PLA General Hospital
Beijing, 100089
About this study
Acute kidney injury (AKI) is a severe complication after liver resection and is associated with morbidity and mortality. The incidence of postoperative AKI is significantly higher in elderly patients, especially in those with comorbidities.
There is currently limited evidence on the incidence and associations of postoperative AKI in elderly patients following liver resection.
This study will evaluate the incidence and associations of AKI in elderly patients after liver resection and its impact on postoperative mortality.
Read the detailed description
The occurrence of postoperative AKI is independently associated with increased morbidity and mortality. Advanced age reduces renal autoregulatory capacity due to physiological and functional changes, thus render the elderly to suffer postoperative AKI and probably the consequent chronic kidney disease.
Although elderly patients account for approximately 25% of surgical procedures, the incidence and associations of AKI in this group of patients are rarely understood.
Thus, it is essential to identify those patients at high risk to develop postoperative AKI to optimize perioperative prevention and protection strategies.
This study is a retrospective cohort study, aim to access risk factors of postoperative AKI and its association with outcomes. The investigators will develop and validate a predictive model for postoperative AKI.
The principal clinical outcome of the study is postoperative AKI, defined as an absolute increase in serum creatinine of 0.3 mg/dL within 48 hours or a 1.5-fold increase from preoperative baseline within seven days after surgery, according to the Kidney Disease: Improving Global Outcomes (KDIGO) criterion.
- Conditions
- Postoperative Acute Kidney Injury
- Being tested
- no intervention
- Keywords
- acute kidney injury, predictive nomogram, elderly, liver resection
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| elderly patients following hepatectomy | elderly patients (aged ≥65 years) scheduled for any type of liver resection Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative acute kidney injury
Postoperative acute kidney injury is defined as an absolute increase in serum creatinine of 0.3 mg/dl within 48 hours or a 1.5-fold increase from preoperative baseline within seven days after surgery, according to the Kidney Disease: Improving Global Outcomes (KDIGO) criterion.
Measured: postoperative seven days
Secondary outcomes (1)
Incidence of postoperative AKI
collection of clinical data in the medical record and follow-up update
Measured: postoperative seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start1 Sep 2020
- Primary completion30 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 843 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weidong Mi, Chinese PLA General Hospital
- Investigators
- Weidong Mi, PhD, Study director, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922866
- Sponsor's protocol ID
- PLAGH-AOC-002
- Status last verified
- Mar 2022
- First submitted
- 7 Jun 2021
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yu Y, Zhang C, Zhang F, Liu C, Li H, Lou J, Xu Z, Liu Y, Cao J, Mi W. Development and validation of a risk nomogram for postoperative acute kidney injury in older patients undergoing liver resection: a pilot study. BMC Anesthesiol. 2022 Jan 13;22(1):22. doi: 10.1186/s12871-022-01566-z.
PubMed 35026992
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Nomogram for Postoperative Acute Kidney Injury (AKI) in Elderly Patients Following Liver Resection
- ClinicalTrials.gov ID
- NCT04922866
- Acronym / sponsor ID
- PLAGH-AOC-002
- Conditions
- Postoperative Acute Kidney Injury
- Keywords
- acute kidney injury, predictive nomogram, elderly, liver resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 843 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute kidney injury (AKI) is a severe complication after liver resection and is associated with morbidity and mortality. The incidence of postoperative AKI is significantly higher in elderly patients, especially in those with comorbidities.
There is currently limited evidence on the incidence and associations of postoperative AKI in elderly patients following liver resection.
This study will evaluate the incidence and associations of AKI in elderly patients after liver resection and its impact on postoperative mortality.
Detailed description
The occurrence of postoperative AKI is independently associated with increased morbidity and mortality. Advanced age reduces renal autoregulatory capacity due to physiological and functional changes, thus render the elderly to suffer postoperative AKI and probably the consequent chronic kidney disease.
Although elderly patients account for approximately 25% of surgical procedures, the incidence and associations of AKI in this group of patients are rarely understood.
Thus, it is essential to identify those patients at high risk to develop postoperative AKI to optimize perioperative prevention and protection strategies.
This study is a retrospective cohort study, aim to access risk factors of postoperative AKI and its association with outcomes. The investigators will develop and validate a predictive model for postoperative AKI.
The principal clinical outcome of the study is postoperative AKI, defined as an absolute increase in serum creatinine of 0.3 mg/dL within 48 hours or a 1.5-fold increase from preoperative baseline within seven days after surgery, according to the Kidney Disease: Improving Global Outcomes (KDIGO) criterion.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| elderly patients following hepatectomy | – | Other: no interventionelderly patients (aged ≥65 years) scheduled for any type of liver resection |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients (aged ≥ 65 years) with benign and malignant liver diseases of the Chinese PLA General Hospital HPB (Hepato-Pancreato-Biliary) Center undergoing liver resection from 2012-2019
Key inclusion criteria (2 listed)
- Elderly patients aged ≥65 years
- Benign and malignant liver diseases
Key exclusion criteria (2 listed)
- Emergency operation
- Liver transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | elderly patients following hepatectomy |
Primary outcome
Postoperative acute kidney injury
Time frame: postoperative seven days
Postoperative acute kidney injury is defined as an absolute increase in serum creatinine of 0.3 mg/dl within 48 hours or a 1.5-fold increase from preoperative baseline within seven days after surgery, according to the Kidney Disease: Improving Global Outcomes (KDIGO) criterion.
1 secondary outcome
Incidence of postoperative AKI
Time frame: postoperative seven days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Derived from this study: PubMed 35026992Yu Y, Zhang C, Zhang F, Liu C, Li H, Lou J, Xu Z, Liu Y, Cao J, Mi W. Development and validation of a risk nomogram for postoperative acute kidney injury in older patients undergoing liver resection: a pilot study. BMC Anesthesiol. 2022 Jan 13;22(1):22. doi: 10.1186/s12871-022-01566-z.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weidong Mi, PhD study director
Chinese PLA General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Acute Kidney Injury, run by Chinese PLA General Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative acute kidney injury (time frame: postoperative seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04922866, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.